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The Infusomat® Space Volumetric Infusion Pump System is an electrical, external, volumetric infusion pump system indicated for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.

The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic infusion pump and pump accessories. The Infusomat® Space utilizes a linear peristaltic pumping mechanism and is intended to provide infusions of parenteral fluids. The system is intended to provide intermittent or continuous flow of parenteral fluids to the patient. Parenteral fluids may include standard fluids and/or medications indicated for infusion as well as blood and blood products. The Infusomat® Space Volumetric Infusion Pump System must be housed in a SpaceStation that has SpaceCom software installed in order to accomplish the advanced features of bar coding and out-bound wireless data transmission. The subject device is a computer- controlled electrical, external, lineal peristaltic infusion pump composed of injection molded thermoplastic components.

The provided 510(k) summary for the B. Braun Infusomat® Space Volumetric Infusion Pump System (K083689) does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm.

This document is a premarket notification for an infusion pump system, focusing on its substantial equivalence to previously cleared devices and new functionalities like barcode scanning, wireless data transmission, and PCA. The performance aspects discussed generally relate to the device's mechanical operation and its ability to administer fluids, blood, and medications, as expected from an infusion pump.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not detail specific, quantifiable acceptance criteria (e.g., accuracy percentages, error rates) for new features like barcode reading or wireless data transmission, nor does it present the results of a primary study demonstrating performance against such criteria. The submission largely relies on predicate device equivalence for demonstrating safety and effectiveness.
2. Sample size used for the test set and the data provenance: Not applicable as no such study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document pertains to a medical device (infusion pump), not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance (as inferred from the document's purpose):

The document asserts the device's performance through:

• Substantial Equivalence: The Infusomat® Space Volumetric Infusion Pump System is considered substantially equivalent to the original cleared Infusomat® Space (K062700). Its new features (barcode, wireless, PCA) are deemed substantially equivalent to the B. Braun Outlook® Safety Infusion System (K011975) and the MEDLEY™ PCA Module (K032233). This implies that the performance of the new features is expected to be comparable to these cleared predicate devices.
• Intended Use: The device is intended to provide infusions of parenteral fluids/medications, blood, and blood products with accuracy and control, as would be expected from any volumetric infusion pump.
• Error Reduction: The document highlights that the barcode, wireless, and PCA features are designed to "enhance the administration of infusions" and are "tools in the development of medication error reduction programs while ensuring the validity of transferred data." This is a goal and intended outcome rather than a quantified performance metric from a study within the document.
• Customization: The system can be customized to meet institutional needs (e.g., enabling/disabling features, assigning dose/rate limits). This speaks to its flexibility and control rather than a specific performance metric.
• Mechanical Integrity: "The mechanics of the Infusomat Space have not changed since the original submission," implying its core pumping mechanism maintains its established performance.

In conclusion, this 510(k) summary describes a traditional medical device and its enhanced functionalities through substantial equivalence arguments, rather than presenting a performance study with detailed acceptance criteria that would typically be found for an AI/ML-based device.

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The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, dedicated administration sets, and pump accessories. The system is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments.

The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, dedicated administration sets, and pump accessories. The Infusomat® Space is a 12V DC or battery powered external, transportable, volumetric infusion pump. The Infusomat® Space utilizes a linear peristaltic pumping mechanism and is intended to provide infusions of parenteral and enteral fluids. The Infusomat® Space is intended for but not limited to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments. A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting. The system created by using the administration sets with the Infusomat® Space is intended to provide intermittent or continuous flow of parenteral and enteral fluids to the patient. Parenteral fluids may include all standard fluids and/or medications indicated for infusion as well as blood and blood products.

Here's an analysis of the provided text regarding the acceptance criteria and study for the B. Braun Infusomat® Space Volumetric Infusion Pump System, based on the requested categories.

It's important to note that the provided 510(k) summary focuses heavily on demonstrating substantial equivalence to predicate devices and describes the device's components and intended use. It does not contain specific acceptance criteria, detailed study designs, or performance metrics in a quantitative manner that would be typically found in a full efficacy study report. Therefore, many sections of your request cannot be fully answered from this document.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given 510(k) summary. The document focuses on demonstrating that the device is "substantially equivalent" to existing predicate devices, implying that its performance meets the generally accepted safety and effectiveness standards for infusion pumps. However, no specific quantitative acceptance criteria (e.g., flow rate accuracy within X%, duration of battery life, etc.) or corresponding performance data are listed.

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the document. The 510(k) summary does not describe any specific clinical or performance testing that would involve a "test set" in the context of efficacy or diagnostic accuracy. The substantial equivalence argument relies on comparing features and intended use with predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable/provided. As there's no described "test set" for performance evaluation against a ground truth in the document, there's no mention of experts or their qualifications for establishing such truth.

4. Adjudication Method for the Test Set

This information is not applicable/provided. No "test set" or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The device described is a volumetric infusion pump, not an AI-assisted diagnostic or interpretation system. Therefore, an MRMC study related to human reading improvement with AI is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The Infusomat® Space is a physical medical device (an infusion pump), not an algorithm that performs standalone analysis. Its performance is inherent in its electromechanical function.

7. The Type of Ground Truth Used

This information is not applicable/provided. No specific ground truth, in the context of diagnostic accuracy or similar, is described as being used for performance evaluation in this 510(k) summary. The "ground truth" for an infusion pump would typically be its physical accuracy and safety parameters, which are assessed through engineering and bench testing, but specifics are not detailed here.

8. The Sample Size for the Training Set

This information is not applicable/provided. The document does not describe the use of machine learning or AI, and therefore, there is no "training set" in this context. The pump's design and engineering would be based on established medical device standards and principles, not statistical data training sets.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided. As there is no training set for an AI/ML algorithm described, the method for establishing its ground truth is also not mentioned.

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